Keeping weight off after stopping GLP-1s using metformin with or without rapamycin or low‑dose naltrexone
Official title: Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation: A Randomized, Controlled Trial
Run by AgelessRx · NCT07092618 · Data updated 2026-11-12
This trial will test whether metformin alone or combined with low‑dose rapamycin or low‑dose naltrexone helps adults 40–85 maintain weight loss after they stop GLP‑1 medications.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | AgelessRx Industry-sponsored |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | August 2025 |
| Study ends | August 2025 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT07092618 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are AgelessRx patients aged 40–85 with BMI ≥22 who have been on GLP‑1 therapy for at least three months and lost at least 15 pounds and who plan to discontinue GLP‑1s.
✕Probably not a fit
Patients with prior bariatric surgery, contraindications to metformin/rapamycin/naltrexone, recent use of other weight‑loss drugs, significant psychiatric illness, or who are pregnant/breastfeeding are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, controlled Phase 2/3 trial at a single AgelessRx site comparing four arms: control (no alternative medication), metformin, metformin plus rapamycin, and metformin plus low‑dose naltrexone. Eligible AgelessRx patients aged 40–85 with BMI ≥22 who have used GLP‑1s for at least three months and lost ≥15 lb will be randomized and followed during a six‑month period after gradual GLP‑1 cessation. The main outcome is percent weight regain over six months, with secondary outcomes including metabolic markers such as HbA1c and other safety measures. The trial uses repurposed, commonly available medications to test practical strategies for weight maintenance after stopping GLP‑1 therapy.
Why it matters
Potential benefit: If successful, the regimen could offer a low‑cost, clinic‑based way to reduce weight regain and improve metabolic measures for people stopping GLP‑1 drugs.
How similar studies have gone: Metformin has some prior evidence for modest metabolic and weight effects, but using metformin combined with rapamycin or low‑dose naltrexone specifically to prevent weight regain after GLP‑1 cessation is largely novel and not established in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Existing AgelessRx patient * Adults (40 - 85 years of age) * Any sex * Any ethnicity * BMI ≥ 22 kg/m\^2 * Have been on GLP-1s (Wegovy, Ozempic, or a compounded form of GLP-1s) for at least three months before study initiation * Have lost at least 15 lbs during their GLP-1 use Exclusion Criteria: * Individuals who are denied a longevity product by the AgelessRx medical team will not be asked to participate in any product specific test(s) or questionnaire(s) * History of bariatric surgery * Use of weight-loss medications other than GLP-1s within the past 6 months * Age \<40 years * Contraindications to naltrexone, metformin, or rapamycin * Significant psychiatric illness that may affect participation * Pregnant or breastfeeding individuals
Where it's running
-
AgelessRx
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Stefanie Morgan, PhD — AgelessRx
- Study coordinator: Sajad Zalzala, MD
- Email: doctor@agelessrx.com
- Phone: (313) 355-8657
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.